Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05507294
Eligibility Criteria:
Inclusion Criteria:
* Subjects has to meet all of the following criteria for study entry:
1. Healthy Chinese male subjects are 18 to 45 years of age, inclusive. "Healthy" in this criterion refers to normal results of medical history interview, physical examinations, vital sign measurements, clinical laboratory tests, chest X-ray (posteroanterior \[PA\]) and 12-lead electrocardiogram (ECGs), or abnormalities with no clinical significance as judged by the investigator.
2. Bodyweight ≥50.0 kg and body mass index (BMI) are between 19.00 and 26.00 kg/m2, inclusive.
3. Subjects should be able to take adequate and effective contraceptive measures and to avoid sperm donation during the study (from the informed consent form \[ICF\] signed to the last visit completed), and within 6 months after the end of the study.
Adequate and effective contraception is defined as the following:
* Complete abstinence: If it is consistent with subject's preference or lifestyle.
* Adhere to the correct use of one of the following birth control measures:
1. Use of an intra-uterine device (IUD) by the subject's female partner; or
2. Barrier measures such as diaphragm or condom.
4. Subjects should sign the ICF voluntarily and understand the purpose, process and risks of the study.
5. Subjects should be able to communicate well with the investigator and comply with the requirements of the clinical study.
Exclusion Criteria:
* Subjects who has any of the following diseases or conditions
1. Known malignancy or psychiatric disorder.
2. Known to suffer from acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease, etc.), pulmonary fibrosis, pulmonary tuberculosis and other diseases that affect respiratory function.
3. Has a history of diabetes mellitus and/or pancreatitis.
4. History of major gastrointestinal surgery (except appendicitis surgery, anal prolapse surgery), such as gastrectomy, gastroenterostomy, enterectomy, gastric bypass, gastric division or gastric banding, etc.
5. Headache ≥2 per week and duration ≥30 minutes within 3 months, or headache episode within 1 week before administration.
Subjects who has any of the following diseases or clinically significant abnormalities at the screening examination
6. Suffering from allergic diseases (such as allergic rhinitis, allergic asthma), had a history of systemic allergic reactions, allergies to any component of the study drug or allergies to similar drugs
7. Uncured pulmonitis, blood system, respiratory system, cardiovascular and cerebrovascular system, and digestive system disorders with clinical significance, and any known diseases that may affect drug absorption, distribution, metabolism and excretion.
8. Mean corrected QT interval (QTcF) at rest \> 450 ms by 12-lead ECG, or other abnormalities with clinical significance in the opinion of the investigator.
9. Positive results for hepatitis B virus surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, treponema pallidum antibody; and non-negative for human immunodeficiency virus (HIV) antibody.
Subjects who has any of the following conditions within a certain period before the screening/baseline (i.e., the day before the first period of administration, D-1) examination
10. Consumed foods that affect the liver drug enzyme CYP3A4 (such as grapefruit or beverages containing grapefruit) or foods or beverages rich in xanthine (such as chocolate, coffee, red bull, etc.) within 48 hours before administration.
11. Use any over-the-counter drugs (including vitamins and herbal supplements, etc., except vitamin-containing beverages) within one week.
12. Use of any prescription drug within 2 weeks or less than 5 half-lives between the last prescription drug and the first dose of Glumetinib, whichever is shorter.
13. Smoking ≥5 cigarettes per day within 3 months or unable to refrain from smoking during the study.
14. Regular drinkers (exceeding 2 units of alcohol per day on average \[1 unit = 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine\]) within 3 months or a positive alcohol breath test at screening/baseline.
15. History of drug abuse within 12 months before screening examination or positive urine drug abuse screening test during the screening/baseline.
16. Blood donation or blood loss ≥300 mL within 3 months.
17. Participation in any other clinical studies (including clinical studies of drugs and medical devices) within 3 months.
18. Other conditions that the investigator considered inappropriate for the subject to participate in the clinical trial.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05507294
Study Brief:
Protocol Section:
NCT05507294